Advanced CQV Engineer - Clayton NC

NNE Inc.; Powhatan (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive salary with annual raises

PTO 160 hours + 14 holidays

Health, dental, vision insurance

8% 401(k) company contribution

Parental leave 14 weeks

Life and disability insurance

Employee referral bonuses

Job summary

NNE Inc. is seeking an Advanced CQV Consultant to lead commissioning, qualification, and validation (CQV) activities for pharmaceutical and life sciences projects.

Serving as the Project Quality Manager (PQM), you will drive quality, compliance, and validation strategies across multidisciplinary teams to deliver successful project outcomes. You will plan, execute, and deliver CQV activities, ensuring alignment with GMP regulations and industry standards.

Qualifications

• 8+ years in CQV, quality, validation, or GMP consulting.
• Experience leading qualification and validation programs for GMP facilities.
• Strong knowledge of GMP regs (FDA, EMA, ICH), GAMP 5, ASTM E2500.
• Experience as Quality Lead, Validation Lead, or Project Quality Manager on complex projects.

Responsibilities

• Lead CQV activities for facilities, utilities, equipment, and computerized systems.
• Act as Project Quality Manager on small to mid-sized projects, defining validation deliverables.
• Align validation strategies with client expectations and regulatory requirements.
• Mentor junior consultants and promote best practices in validation and quality.

Skills

CQV Leadership

Regulatory Knowledge

Quality Risk Mgmt

Client Relations

Education

Bachelor's or Master's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Job description

At NNE, we help pharmaceutical and biotech companies design and deliver the facilities and processes that improve lives. As an Advanced CQV Consultant, you will lead commissioning, qualification, and validation activities across complex life sciences projects. Serving as a Project Quality Manager (PQM), you will drive quality, compliance, and validation strategies that meet client, industry, and regulatory requirements while collaborating with multidisciplinary teams to deliver successful project outcomes.

Primary Duties and Responsibilities:

As an Advanced CQV Consultant, you are responsible for planning, executing, and delivering commissioning, qualification, and validation (CQV) activities for pharmaceutical, biotechnology, and life sciences projects. Serving as the Project Quality Manager (PQM) on assigned projects, you ensure validation strategies, quality processes, and compliance requirements align with customer expectations, industry standards, and regulatory requirements. This role provides technical leadership throughout the validation lifecycle while supporting multidisciplinary project teams and client stakeholders.

Key Responsibilities

CQV Execution

• Lead commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, and computerized systems.
• Develop and review CQV lifecycle documentation, including validation plans, risk assessments, IQ/OQ/PQ/PfV protocols, traceability matrices, and summary reports.
• Execute qualification activities, troubleshoot technical and compliance challenges, and ensure compliance with GMP regulations, industry standards, and company procedures.
• Collaborate with engineering, automation, quality, and manufacturing teams while supporting FAT, SAT, startup, and commissioning activities.
• Identify and elevate project risks, scope changes, and compliance concerns.

Project Quality Management

• Serve as Project Quality Manager (PQM) on small to mid-sized projects, defining and managing validation and quality deliverables.
• Align project quality strategies with client expectations and regulatory requirements, while monitoring budgets, resources, risks, and quality outcomes.
• Support Quality Assurance Plans (QAPs), facilitate GMP, GEP, ASTM E2500, and design reviews, and provide quality oversight across project disciplines.
• Act as a trusted advisor to both project teams and clients on quality and compliance matters.

Client, Leadership & Business Support

• Build strong client relationships and provide technical guidance on CQV and validation strategies.
• Support proposals, project planning, cost estimates, and business development activities.
• Present project progress, risks, and mitigation plans to stakeholders and leadership.
• Mentor junior consultants, promote validation and quality best practices, and contribute to knowledge-sharing and continuous improvement initiatives.

Required Qualifications

Education & Experience

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
• 8+ years of CQV, Quality, Validation, or GMP consulting experience within the pharmaceutical, biotechnology, or life sciences industry.
• Experience leading qualification and validation programs for GMP-regulated facilities.
• Experience as a Quality Lead, Validation Lead, or Project Quality Manager on complex projects.
• Strong knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, ISPE Baseline Guides, Quality Risk Management, Data Integrity, and Validation Lifecycle Management.

Preferred Qualifications

• Experience supporting large capital projects, clean utilities, process equipment, facilities, and automation systems.
• PMP, ASQ, ISPE, or similar professional certification.
• Client-facing consulting experience.

What we offer you

• Competitive salary with annual adjustment increases
• 160 hours of PTO (prorated from hire date) + 14 paid holidays
• Health, dental, and vision insurance from day one
• 8% guaranteed 401(k) company contribution
• 14 weeks paid parental leave
• Company-paid life and disability insurance
• Employee referral bonuses

This position is not eligible for employer-sponsored work authorization. Candidates must have unrestricted authorization to work in the United States and must not require current or future sponsorship to maintain that authorization.

Deadline of application is 9/25/2026

Wewill invite to interviews on a running basis.